The following data is part of a premarket notification filed by General Biometrics, Inc. with the FDA for Immunowell Cardiolipin Antibody (igm) Test.
| Device ID | K920401 |
| 510k Number | K920401 |
| Device Name: | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
| Contact | Bryan L Kiehl |
| Correspondent | Bryan L Kiehl GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
| Product Code | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-29 |
| Decision Date | 1992-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613745031002 | K920401 | 000 |